Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: FreeStyle Libre System plus food app; Device: FreeStyle Libre System

• Registration Number: NCT04843527
• Lead Sponsor: Abbott Diabetes Care

Brief Summary

A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Detailed Description

Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.

The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.

Study Timeline

• Study Start: 2021-04-02
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-13
• Status Verified: 2024-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Subject must be at least 18 years of age.
• Subject has been diagnosed with type 2 diabetes.
• HbA1c greater than or equal to 7.5% and less than or equal to 12%
• Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
• Subject owns a compatible smartphone
• Subject agrees to a 3-month period of no diabetes medication changes.
• Subject is willing to make diet and lifestyle changes in response to education and glucose data

Exclusion Criteria

• Subject is currently on insulin therapy or sulfonylurea-based medications.
• Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
• Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FreeStyle Libre plus food logging	FreeStyle Libre System plus food app	Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.
FreeStyle Libre	FreeStyle Libre System	Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.

Primary Outcome Measures

Name	Time	Method
Impact on time above 180 mg/dL	Three (3) months	To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL

Trial Locations

Locations (4)

HealthPartners Institute dba International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

UMPC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States